What is this study about pain control after TURP?

This study is testing a new pain management method after transurethral resection of the prostate (TURP) that aims to reduce opioid use. Researchers are comparing the usual care with a multi-modal protocol that includes different types of pain relief and patient education. The goal is to find effective pain control while lowering opioid use, supported by the Benaroya Research Institute.

Who may be eligible for this pain control clinical trial?

Men aged 18 or older who are candidates for TURP and can speak English may be eligible. People who have used opioid prescriptions recently, have allergies to study medications, or have certain health conditions affecting kidneys, liver, or digestion may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this pain control clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses vary and may not be covered. Participants should plan accordingly for any travel or accommodation needs.

Actively Recruiting

Phase 4

Age: 18Years +

MALE

Healthy Volunteers

ID04102566

Improving Pain Control After Transurethral Resection of the Prostate Using a Multi-Modal Approach to Reduce Opioids

Led by Benaroya Research Institute · Updated on 2019-09-27

Participants Needed

Research Sites

8 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a new approach to managing pain after transurethral resection of the prostate TURP that aims to reduce opioid use. The study compares a multi-modal pain control protocol, which combines two or more pain relief agents acting by different mechanisms, to the current standard care that primarily uses opioids. The goal is to provide similar pain relief while minimizing opioid use, addressing concerns related to the opioid epidemic in surgical patients. Participants are randomly assigned to one of two groups. The standard care group receives medications including topical lidocaine gel, acetaminophen, oxycodone, and other supportive drugs both during hospitalization and after discharge. The multi-modal group receives a regimen that adds ibuprofen and patient education about pain and opioid use, aiming to reduce opioid consumption. Both groups get similar supportive medications for urinary symptoms and constipation. The study period includes inpatient treatment and discharge medication prescriptions. During the study, participants opioid use and pain levels are monitored from post-anesthesia care through 72 hours after surgery. Researchers also track the presence of urinary catheters at discharge, side effects from narcotics within 48 hours after discharge, and any post-operative complications. Participants are evaluated through medication usage records and pain scores to assess the effectiveness of the pain management protocols, ensuring careful monitoring of safety and outcomes throughout the study.

CONDITIONS

Brief Title

Optimizing Pain Control in Transurethral Resection of the Prostate

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	Multi-modal group: Ibuprofen, education, and limited inpatient oxycodone (no narcotics on discharge)	Standard post-operative pain management (as locally practiced)
What it is	A structured pain control approach after TURP that adds ibuprofen 600 mg dosing while in hospital, includes specific patient education about pain management after surgery, aims to minimize oxycodone exposure, and does not discharge patients with narcotics.	The usual pain relief methods used after TURP at the study site, which may include narcotics and other medications, but without the structured multi-modal program.
Role in the trial	Test if adding scheduled ibuprofen and education while limiting narcotics improves pain control and reduces opioid use after TURP.	Serves as the comparator to determine if the multi-modal approach provides benefit over the site's typical post-surgical pain management.
Primary use	Designed to improve pain relief after TURP and decrease inpatient and post-discharge opioid use.	Provides symptomatic pain management using medications and care practices as locally determined after TURP surgery.
How it is given or performed	Patients receive regular oral ibuprofen (600 mg per dose) while in hospital, post-operative education, with restrictions on oxycodone use and no provision of narcotics on discharge.	Pain medications are provided according to routine practice and provider discretion, which may include narcotics and non-narcotics.
Evidence status	The combination of scheduled non-opioid medication (NSAIDs) and patient education is supported by national guidelines as effective for acute post-surgical pain. The trial will determine whether this specific regimen reduces opioid use and improves pain control for TURP patients.	Practice guidelines endorse use of non-opioid analgesics such as NSAIDs and acetaminophen as first-line options after surgery, with opioids to be minimized or reserved for unrelieved pain.
Important limitations	The approach excludes patients with medical contraindications to NSAIDs or acetaminophen and may not be appropriate for individuals at risk for adverse events from these medications.	Variations in local prescribing and potential for opioid overuse remain a challenge. Direct comparison to centers with different baseline pain practices is limited.

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

Who Can Participate

Age: 18Years +

MALE

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Identified as candidates for TURP
18 years of age or greater
Proficient in English

You will not qualify if you...

Filled an opioid prescription in the last 2 months
Allergy to any medication included in the protocol
History of pelvic radiation
Renal failure with serum creatinine greater than 2.0 mg/dl
Peptic ulcer disease
History of gastric bypass
Cirrhosis or other contraindications to NSAIDs
Liver failure, hepatitis, or alcohol abuse preventing acetaminophen use

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Hospital stay (0 to 48 hours)

Participants undergo transurethral resection of the prostate (TURP) and receive assigned pain control management while hospitalized, either standard care or a multi-modal pain management protocol including medication and education.

1 hospital stay with medication administration

Post-operative Follow-up

Duration - Up to 72 hours after surgery

Participants are monitored for pain control, opioid consumption, presence of urinary catheter, narcotic side effects, and any post-operative complications after discharge.

Follow-up assessments within 72 hours post-surgery